The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement activities. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.

F1 Foods Inc. D/B/A Flavor First Foods Inc.
West Bridgewater, MA

A food firm in Massachusetts is on notice from the U.S. Food and Drug Administration (FDA) for various federal violations and not maintaining the facility in a clean and sanitary condition. Issues cited include the presence of insects and rotting fruit.

In a March 14, 2024, warning letter, the FDA described a July 18 through Aug. 15, 2023, inspection of Flavor First Foods Inc.’s ready-to-eat (RTE) prepared foods processing facility in West Bridgewater, MA.

FDA investigators found serious violations of the Emergency Permit Control regulation, Acidified Foods regulation, Seafood Hazard Analysis and Critical Control Point (HACCP) regulation, and the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule).

After the inspection, the FDA investigator issued a Form FDA-483, Inspectional Observations, listing deviations found at their facility.

Some of the significant violations are as follows:

Acidified Foods Violations:

1. The firm failed to provide the FDA, before packing any new product, information on the scheduled processes from a qualified person filed with FDA for their (redacted by the FDA) Marinara Sauce as required. Specifically, no scheduled processes are on file for (redacted by the FDA) Marinara Sauce in any size or container the firm produces and distributes.

2. The firm failed to have operators of processing and packaging systems under the operating supervision of a person who has attended and satisfactorily completed a school approved by the FDA for pH controls and critical factors in acidification, as required. Specifically, no one in their facility has attended a Better Process Controls course or any other approved FDA training in the manufacturing of acidified foods.

Seafood HACCP Violations:

The firm must implement the monitoring procedures and frequency that they have listed in their HACCP plan. However, the firm did not implement the monitoring procedures at the following critical control points listed in their HACCP plan for refrigerated, ready-to-eat, heat treated, clam chowder in reduced oxygen packaging:

1. The firm did not follow the monitoring procedure of continuous monitoring of the product temperature to ensure minimum internal temperature of (redacted by the FDA) at the Hot Fill CCP with a (redacted by the FDA) inspection of the continuous time and temperature recording chart before starting each batch. They are not continuously monitoring the time and temperature and do not use a continuous monitoring device for either their cooking kettle or their holding tank. They were observed using a stem thermometer to monitor the temperature of the clam chowder before filling. FDA recommends continuous temperature monitoring at the hot fill step to ensure the cooked soup is hot filled at or above (redacted by the FDA).

2. The firm did not follow the monitoring procedure of “maintain temp at (redacted by the FDA)” at the Cooking CCP to control pathogenic bacteria survival through cooking. On July 26, 2023, they were observed taking only a single temperature during the cooking step for a batch of clam chowder which was observed to be (redacted by the FDA); however, they did not continue to measure the temperature for a period of (redacted by the FDA) to ensure that the clam chowder stayed at (redacted by the FDA) to ensure pathogen reduction as required by their HACCP plan. Furthermore, the first several bags of finished clam chowder that were used to prime the bagging system were reintroduced back into the kettle and never reverified time/temperature requirement of a (redacted by the FDA) as required by their HACCP plan. FDA recommends monitoring of the cook step be conducted using a continuous temperature recording device installed where it measures the coldest temperature in the cook vessel and through visual observation at the start and end of each cook cycle for each batch.

3. The firm did not follow their monitoring procedure of monitoring the water bath for residual chlorine using a (redacted by the FDA) before the use of the water bath at the Cooling After Cooking CCP to control the hazard of post-production contamination. They did not implement this monitoring procedure. Additionally, during the inspection on July 26, 2023, finished sealed bags of clam chowder were observed being cooled in water which was recovered water from their ice machine condensate drainpipe that was untreated. The finished bags of clam chowder were cooled in this water for approximately (redacted by the FDA) before being transferred to separate vats of ice water which was made with (redacted by the FDA) water and ice but was not monitored with (redacted by the FDA) for residual chlorine as required by their HACCP Plan. In addition, the Cooling After Cooking CCP should include a critical limit that ensures residual chlorine is present in the cooler water.

Current Good Manufacturing Practice:

1. The firm did not take reasonable measures and precautions to ensure that all persons working in direct contact with food wash hands thoroughly (and sanitize if necessary to protect against contamination with undesirable microorganisms) in an adequate hand-washing facility before starting work, after each absence from the work station, and at any time when the hands may have become soiled or contaminated, as required. Specifically, on July 18, 2023, during the production and packaging of RTE marinara sauce in 24 oz. glass jars with a manufacturing date of July 18, 2023, the firm’s owner was observed not wearing gloves and 2 other employees were observed wearing soiled gloves while (redacted by the FDA) capping finished filled jars of RTE marinara sauce with several instances of both the owner and the employees observed touching the rim of the jar during the capping process. During this process the owner and the other employees were observed touching other pieces of non-food contact equipment and then going back to (redacted by the FDA) capping the jars. The owner and the employees were not observed washing or sanitizing hands before, during, or after touching nonfood contact surfaces where the hands may have become soiled or contaminated.

2. The firm did not maintain buildings, fixtures, and other physical facilities of their plant in a clean and sanitary condition and in repair adequate to prevent food from becoming adulterated, as required. Specifically,
    a. On July 18, 2023, rusted metal plates with black debris and a white substance were observed directly above exposed glass jars of marinara sauce that were in the process of being filled.
    b. On July 18, 2023, clutter was observed along the walls and floor wall junctures of the dry storage area including but not limited to the storage of old plastic totes, pallets, old equipment, maintenance supplies, puddles of old standing water.
    c. On July 26, 2023, the stem thermometer used to measure the temperature of their clam chowder was observed stored in a PVC pipe that was soiled with a brown substance. There was condensate dripping directly inside the pipe. Several rusty metal steam pipes with dripping condensate were located directly next to the stored thermometer. The investigator observed dripping condensate come into direct contact with the thermometer.
    d. The firm does not have a bathroom inside their facility. Employees must access the adjacent firm to use a bathroom. On July 26, 2023, this bathroom was noted with cobwebs, black dirt and the toilet fixtures and wash sinks were soiled and not clean. The floor of the bathroom had clutter and black dirt. The entrance to the bathroom was cluttered with old equipment, trash, and debris on the floor.

3. The firm did not take effective measures to exclude pests from the manufacturing, processing, packing, and holding areas to protect against the contamination of food on the premises by pests, as required. Specifically,
    a. On July 18, 2023, multiple flying insects were observed by the manufacturing, packaging, and holding areas.
    b. On July 26, 2023, (redacted by the FDA) bushels of apples with a total weight of (redacted by the FDA) pounds were stored on the production floor in a broken walk-in cooler where they package products. The apples were in various stages of quality including many that were bruised and rotting. Fruit flies and other flying insects were noted in the immediate area.

4. The firm did not clean non-food-contact surfaces of equipment in a manner and as frequently as necessary to protect against allergen cross-contact and against contamination of food, food-contact surfaces, and food-packaging materials, as required. Specifically,
    a. On July 18, 2023, during the packaging/capping of marinara sauce, metal caps that were being used to cap the jars were observed to be stored exposed, in an open soiled white container.
    b. On July 26, 2023, the firm and another employee were observed using a (redacted by the FDA) to (redacted by the FDA) the floor and the side surface of the kettle where the clam chowder batch (redacted by the FDA) was being actively cooked with the cover of that kettle in the partial upright position, exposing the clam chowder to aerosols from (redacted by the FDA). Overspray and mist from the (redacted by the FDA) was observed contacting the surface of the lid to the kettle.

5. The firm did not conduct all food manufacturing, processing, packing, and holding under such conditions and controls as are necessary to minimize the potential for the growth of microorganisms and contamination of food, as required by 21 CFR 117.80(c)(2). Specifically,
    a. On July 18, 2023, multiple (redacted by the FDA) sealed bags of acidified marinara sauce Lot (redacted by the FDA) were observed being (redacted by the FDA) in (redacted by the FDA) of untreated water which was recovered water from their ice machine drainpipe. This process is used for all their (redacted by the FDA)-sealed bagged products including the refrigerated RTE, Reduced Oxygen Packaged, (redacted by the FDA) Treated Not Shelf Stable Clam Chowder. These processes can lead to the product becoming contaminated as the bags being (redacted by the FDA) in the untreated (redacted by the FDA) water may have faulty seals allowing the (redacted by the FDA) water from the ice machine to enter the bags.
    b. On July 18, 2023, during the packaging of the jarred marinara sauce, the product transfer hose that was transferring the marinara sauce from the cooking kettle to the hot fill kettle was observed in direct contact with the floor.

6. The firm did not maintain the grounds around their plant in a condition adequate to protect against the contamination of food by properly storing equipment and removing litter and waste that may constitute an attractant, breeding place, or harborage for pests, as required. Specifically, outside of the facility, the FDA investigator observed overflowing dumpsters, an old camper with broken windows and broken open door, and other discarded equipment providing harborages for rodents, birds, and pests.

The full warning letter can be viewed here.

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